Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

Summary

The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.

The main questions it aims to answer are:

* Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?
* Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?
* What is the prevalence of sleep apnea among high-risk individuals in Greenland?
* Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?

Participants will:

* Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness
* Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy
* Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation
* Blood samples for full genome sequencing

Conditions

• Diabetes Mellitus, Type 2
• Obesity, Morbid
• Obstructive Sleep Apnea
• MODY
• Diabetic Retinopathy
• Diabetic Neuropathies

Interventions

GENETIC

Whole genome sequencing

Screening for MODY diabetes. Diabetic treatment will be adjusted based on the participant's diabetic genotype.

DIAGNOSTIC_TEST

VAGUS

To examine for Cardiovasculare Autonomic Neuropathy participants will be tested with the handheld Vagus device (Medicus Engineering, Aarhus, Denmark). Participants are instructed to perform three cardiovascular reflex tests (CARTs) after lying still in supine position for 5 minutes to record heart rate at rest. CARTs include supine-to-upright position, deep-breathing, and valsalva maneuver. From each CART the ratio based on the shortest and longest R-R-interval at predefined timepoints in the recording is used to assess the possibility of CAN

DIAGNOSTIC_TEST

NightOwl

Participants will be examined for sleep apnea for 3 nights using the NightOwl (Ectosense, Belgium) device, which measuring Peripheral Arterial Tonometry (PAT) in the index finger. The results of the examination will is uploaded via the patient's smartphone to an online platform accessible to healthcare providers. Participants with signs of sleep apnea will receive a confirmatory cardiorespiratory monitoring using the Nox T3s (Noxturnal, ResMed), and the results will be compared.

DEVICE

CPAP

Participants with an Apnea-Hypoapnea-Index above 30, or above 15 with symptoms of sleep apnea, will be offered treatment with continuous positive airway pressure (CPAP).

Sponsors & Collaborators

• Zealand University Hospital

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Steno Diabetes Center Greenland

  lead OTHER

Principal Investigators

• Marit Eika Jørgensen, Md. Phd · Steno Diabetes Center Greenland

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-15

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Greenland

Study Locations